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510(k) K972865

PROMEX ENT TISSUE REMOVAL SYSTEM by Promex, Inc. — Product Code ERL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1997
Date Received
August 4, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device Class
Class II
Regulation Number
874.4250
Review Panel
EN
Submission Type

Other clearances by Promex, Inc.

  • K023450 — BIOPSY SITE TISSUE MARKER DEVICE (December 19, 2002)
  • K022634 — CO-AXIAL INTRODUCER NEEDLE (November 6, 2002)
  • K010400 — VACUUM ASSISTED CORE BIOPSY DEVICE (July 24, 2001)
  • K011270 — AUTOMATED CORE BIOPSY DEVICE (June 22, 2001)
  • K001132 — BONE BIOPSY NEEDLE (May 1, 2000)
  • K994272 — AUTOMATED CORE BIOPSY DEVICE (January 7, 2000)
  • K993435 — MANUAL BONE MARROW BIOPSY DEVICE (December 6, 1999)
  • K973184 — PROSTATE SEEDING NEEDLE (November 21, 1997)
  • K961078 — AUTOMATED VITRECTOMY DEVICE (June 14, 1996)
  • K960023 — KIRSHNER WIRES (K-WIRE) & STEINMANN PINS (March 18, 1996)

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